Recently approved medications and those already on the market can benefit from pharmacovigilance to help ensure patient safety. While pharmacovigilance practices are highly regulated in the context of clinical trials, post-marketing incidence reporting is not properly adopted or enforced. As a result, it is anticipated that adverse events related to medications that are already in the market are underreported by about 90%. Therefore, it can be difficult to identify drug safety problems in individuals who have numerous comorbid conditions and complex disorders.
What is Pharmacovigilance?
The research and practices involved in the identification, evaluation, comprehension, and avoidance of side effects or any other issue involving medications is known as pharmacovigilance.
Before a treatment is approved for use, the only available proof of its efficacy and safety comes from clinical trials, in which patients are carefully chosen and monitored under carefully controlled settings. This indicates that a treatment has only undergone brief testing in a very small number of carefully chosen patients at the time of its authorization.
Following approval, the medication may be administered to a large number of patients, continuously, and in conjunction with other medications. In such cases, some adverse effects could manifest. Therefore, it is crucial to continuously assess the safety of all medications used in medical procedures.
How is Drug Safety Ensured?
For the evaluation of prescription medications, there are regulatory frameworks. First, the FDA examines the efficacy and safety of new pharmaceuticals that manufacturers want to market in the United States during the premarket approval process. The FDA’s examination of the studies in which people use the investigational new medicine in meticulously controlled, typically randomized trials such as Phase 1, 2 and 3 trials.
Second, the FDA takes action through its post market regulatory processes once a maker has sufficiently shown a drug or device safety and effectiveness for a specific population and set of conditions. Clinicians and patients may also report any significant or unusual adverse effects to the FDA.
According to the law, the FDA is authorized to take only limited action if it determines that a product’s post-approval use entails a higher risk of a negative outcome. However, many argue that in addition to needing a wider variety of enforcement measures, FDA also has to make better use of the authority it already possesses.
Six areas are discussed, including the FDA budget, the industry’s role, the opportunity to leverage the drug approval process to improve post market operations, the paucity of post-market data, and the limited public access to data obtained. The FDA is able to execute some of the recommended adjustments. Others would necessitate legislative action.
It is important to understand that no medication is 100% risk-free. A prescription drug is actually one that has “toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug,” according to the Federal Food, Drug, and Cosmetic Act.
Therefore, it is important to ensure that the drug safety plan is working in all areas of the healthcare sector to ensure utmost safety. Regulatory authorities and pharmaceutical medicine pupils must adhere to the fundamental principle and primary objective of pharmacovigilance.
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The theory and definitions of drug safety — pharmacovigilance. (2019). Cobert’s Manual of Drug Safety and Pharmacovigilance, 1–7. https://doi.org/10.1142/9789813278851_0001
Yehia, D. H. (2022, June 24). Introduction to pharmacovigilance: How drug safety is enforced by pharmacovigilance – pharmacovigilance foundations. Pharmacovigilance Foundations – Simplifying Healthcare Professionals Workspace. Retrieved September 24, 2022, from https://www.pharmacovigilancefoundations.com/pharmacovigilance-introduction/